OBJECTIVE: To evaluate the quality of Huzhang antidote granules（sugar-free） and establish the quality standard. METHODS: The quality of Huzhang antidote granules（sugar-free） was investigated with reference to Chinese Pharmacopoeia（2020）. Qualitative identification method of polygonum cuspidatum

radix isatidis and Chuanshegan in preparations was established by thin-layer chromatography（TLC）

and content determination method of polydatin and emodin was established by high performance liquid chromatography. The contents of polydatin and emodin in three batches of samples were determined

and the stability of the particles was investigated. RESULTS: The particle size

water content

solubility and loading difference of Huzhang antidote granules（sugar-free） were in line with the regulations. Results of TLC identification showed that the chromatographic spots of polygonum cuspidatum

Chuanshegan and radix isatidis were clear

and the negative samples had no interference. Results of high performance liquid chromatography showed that polydatin and emodin had good linear relationship in the range from 0.017 7 μg to 0.176 6 μg and from 0.014 6 μg to 0.145 6 μg respectively（r=0.999 8

0.999 9）. RSD of the precision

stability and repeatability tests were all ≤2%（n=6）

and the average recovery rates were 98.79%（RSD=1.97%

n=9） and 101.53%（RSD=1.63%

n=9）. Tentatively

each bag containing polygonum cuspidatum shall not be less than 8 mg/g in polydatin. Each bag containing polygonum cuspidatum shall not be less than 5 mg/g in emodin. The particle quality was stable during the inspection. CONCLUSIONS: The quality standard established by this study can be used for quality control of Huzhang antidote granules（sugar-free）.